# FDA recall Z-2273-2025

> **Boston Scientific Corporation** · Class I · device recall initiated 2025-07-07.

## Product

Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system.    Material numbers:    H7493915010240  CAROTID WALLSTENT MONORAIL 10.0-24;  H7493915010310  CAROTID WALLSTENT MONORAIL 10.0-31;  H749391506220  CAROTID WALLSTENT MONORAIL 6.0-22;  H749391508210  CAROTID WALLSTENT MONORAIL 8.0-21;  H749391508290  CAROTID WALLSTENT MONORAIL 8.0-29;  H965SCH647010  CAROTID WALLSTENT MONORAIL 6.0-22;  H965SCH647070  CAROTID WALLSTENT MONORAIL 8.0-21;  H965SCH647080  CAROTID WALLSTENT MONORAIL 8.0-29;  H965SCH647090  CAROTID WALLSTENT MONORAIL 8.0-36;  H965SCH647120  CAROTID WALLSTENT MONORAIL 10.0-24;  H965SCH647130  CAROTID WALLSTENT MONORAIL 10.0-31;  H965SCH647140  CAROTID WALLSTENT MONORAIL 10.0-37;  M001719000  CAROTID WALLSTENT MR 6X22 5F 135CM;  M001719010  CAROTID WALLSTENT MR 8X21 5F 135CM;  M001719020  CAROTID WALLSTENT MR 8X29 5F 135CM;  M001719030  CAROTID WALLSTENT MR 8X36 5F 135CM;  M001719040  CAROTID WALLSTENT MR 10X24 5.9F 135CM;  

## Reason for recall

Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.

## Distribution

Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide.

## Key facts

- **Recall number:** Z-2273-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-07
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2273-2025

## Citation

> AI Analytics. FDA recall Z-2273-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2273-2025. Source: US FDA. Licensed CC0.

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